MTA-Fillapex is a root canal sealer intended for the permanent scaling of root canals and may be used in combination with root canal obturation materials.

Device Description

MTA Fillapex is a mineral trioxide aggregate (MTA) and resin toot canal sealer used during endodontic treatment to permanently fill the canal system following debridement and disinfection. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. Being hydrophilic in nature, MTA-FILLAPEX is desirable as a root filling material because an isolated dry field is not necessary for use. Moisture does not negatively affect the sealing ability and is required for proper setting. It is used in combination with gutta-percha or silver points during root canal obturation.

AI/ML Overview

The provided text describes the 510(k) submission for MTA Fillapex, a root canal sealer. It details performance criteria and tests conducted to demonstrate substantial equivalence to predicate devices, especially a modified version of K113568 with the addition of titanium dioxide to the base paste. However, this document does not describe a study, or acceptance criteria, for a device that uses AI. Instead, it's for a dental material (root canal sealer). Therefore, many of the requested fields related to AI/algorithm performance are not applicable.

Here's an analysis based on the provided text, focusing on the material it does describe:

1. Table of acceptance criteria and the reported device performance

Test Performed	Acceptance Criteria	Reported Device Performance (MTA Fillapex)	Source (pages)
Working time	23 minutes	23 minutes	2, 3
Setting time	130 minutes	Minimum 130 minutes (Table 1), 130 minutes (Table 2)	1, 3
Flow	Minimum of 20 mm	33.38 mm (Table 1)	1, 3
Radiopacity	Minimum of 3 mm	Greater than 3mm of the aluminium scale	3
Solubility	Maximum 3%	2.47% (Table 1)	1, 3
Internal Tests
Flow/Viscosity (Base Paste)	20-22 mm	Not explicitly stated for specific paste, but "Flow: 33.38 mm" is reported for the mixed product	1, 3
Flow/Viscosity (Catalyst Paste)	27-29 mm	Not explicitly stated for specific paste, but "Flow: 33.38 mm" is reported for the mixed product	1, 3
Flow/Viscosity (Mixed pastes after 30 min)	21-23 mm	Not explicitly stated for specific paste, but "Flow: 33.38 mm" is reported for the mixed product	1, 3
Radiopacity	Greater than 3mm of the aluminium scale	Greater than 3mm of the aluminium scale	3
Setting time	130 minutes	130 minutes	3
Free lime content	3-5%	Not explicitly stated in performance (only acceptance criteria)	3
Biocompatibility	Biocompatible	Biocompatible (based on prior K113568 testing)	1, 2
Shelf Life	2 years	2 years	1, 2

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for each test beyond numerical results (e.g., "33.38 mm" for flow). The data provenance is also not specified in terms of country of origin or whether it was retrospective or prospective. The tests were performed as "Design Verification Tests" in response to a "Failure Modes and Effects Analysis (FMEA)" related to a modification (addition of titanium dioxide).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is for a dental material, not an AI/software device requiring expert ground truth for classification or diagnosis. Performance metrics are based on physical and chemical properties and industry standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is for a dental material; there is no adjudication process involving multiple human readers for performance metrics like flow or setting time.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is for a dental material, not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is for a dental material, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the physical and chemical properties (flow, setting time, solubility, radiopacity, etc.), the "ground truth" is established by adherence to industry standards (specifically ISO 6876:2012) and established laboratory testing protocols. For biocompatibility, reliance is placed on previous testing for the predicate device (K113568) and the chemical composition.

8. The sample size for the training set

Not applicable. This is for a dental material, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is for a dental material, not an AI model.

Summary

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140247

APR 2 5 2014

Image /page/0/Picture/2 description: The image contains the logo for Angelus Science and Technology. The logo features a stylized letter 'A' inside of a circle on the left. To the right of the circle is the word 'angelus' in lowercase letters, and below that is the phrase 'science and technology' in smaller letters.

510(k) Summary

Proprietary Name	MTA Fillapex
K Number	K140247
Date Prepared	April 25, 2014
Submitter	Angelus Industria de Productos OdontologicosWaldir Landgraf, 101Londrina, Brazil 86031-3200
Telephone:	+55 43 2101 3200
Official Contact	Tara ConradTechLink International Consulting18851 NE 29th Avenue Suite 720Aventura, FL 33180TEL- (305) 377-0077
Common Name:	Resin, Root Canal Filling
Trade Name:	MTA Fillapex
Classification:	Class II
Product Code:	KIF
Classification Panel:	Dental
Regulation Numbers:	21 CFR 872.3820
Substantial Equivalence:	K113568 MTA Fillapex by AngelusK010940 Sealapex by Sybron

Description of Proposed Device

Indications for Use

MTA-Fillapex is a root canal sealer intended for the permanent scaling of root canals and may be used in combination with root canal obturation materials.

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Image /page/1/Picture/0 description: The image shows the logo for Angelus Science and Technology. The logo features a stylized "A" inside of a black circle on the left. To the right of the circle is the word "angelus" in lowercase letters. Below the word "angelus" is the phrase "science and technology" in a smaller font.

Device Comparison Table

	Subject Device	Predicate Device
	MTA Fillapex by Angelus	K113568 MTA Fillapex by	K010940 Sealapex by
	K140247	Angelus	Sybron
Indications for use	MTA-Fillapex is a root canalsealer intended for thepermanent scaling of rootcanals and may be used incombination with root canalobturation materials.	MTA-Fillapex is a root canalsealer intended for thepermanent scaling of rootcanals and may be used incombination with root canalobturation materials.	Sealapex 4 is acalcuium hydroxide,polymeric resin, rootcanal filling materialthat is used inconjunction with guttapercha or silverendodontic points.
Design	Two paste system(base/catalyst)	Two paste system(base/catalyst)	Two paste system(base/catalyst)
Flow	33.38 mm	27.66mm	25.15 (±1.73) mm (1)
Material components	Dicalcium andtricalcium silicate,tricalcium aluminate,calcium oxide,pentaerythritolrosinate, n-ethyl-o,p-toluenesulfonamidesalicylate resin,bismuth oxide, fumedsilica, titanium dioxide	Dicalcium andtricalcium silicate,tricalcium aluminate,calcium oxide,pentaerythritolrosinate, n-ethyl-o,p-toluenesulfonamidesalicylate resin,bismuth oxide, fumedsilica, titanium dioxide	Titanium Dioxide,Fumed Silica, BismuthTrioxide, Isobutylsalicylate resin, N -ethyl toluenesolfanamide resin,Calcium Oxide, ZincDioxide
Working time	23 minutes	35 minutes	Minimum 120 minutes
Setting time	Minimum 130 minutes	Minimum 130 minutes	45 minutes afterplacement
Solubility	2.47%	0.1%	>4% (2)
Shelf Life	2 years	2 years	2 years
Biocompatibility	Biocompatible	Biocompatible	Biocompatible
Standards	ISO 6876:2012	ISO 6876: 2001	ISO 6876: 2001

Substantial Equivalence

The subject device and the predicate devices have intended use and have the same technological characteristics, including the same range of physical and chemical properties. The subject and predicate devices are packaged in similar materials and utilize similar methods of application. Any differences in the technological characteristics do not raise new issues of safety or efficacy.

Performance Data

MTA Fillapex is a modification of K113568. They are designated for the equivalent dental applications and have comparable chemical and physical properties, and performance specifications. An additional predicate device (K010940) includes each specific chemical component that is equivalent to those found in MTA Fillapex, providing evidence that these materials are safe and effective for medical device use. Furthermore, MTA Fillapex and K113568 have equivalent packaging containers and delivery systems.

MTA Fillapex has undergone the following testing:

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These tests have shown that MTA Fillapex and K113568 are substantially equivalent to the new MTA Fillapex. Both devices have comparable flowability, working times, setting times, dimensional change following setting, solubility, shelf life and biocompatibility properties.

Since MTA Fillapex's chemical composition is based on the principal chemical components in K113568, the biocompatibility test provides evidence that the product is non-mutenagenic, does not cause an allergenic potential after multiple uses and has a good tolerance. The shelf life, bench and biocompatibility testing, provide evidence that the chemical and physical properties are substantially equivalent.

Design Control Activities

The risk analysis method used to assess the impact of the modifications was a Failure Modes and Effects Analysis (FMEA) The design verification tests that were performed as a result of the risk analysis assessment are listed in the table below:

Modification	Test Performed	Acceptance criteria
Titanium dioxide wasadded to the base paste	1. Working time2. Setting time3. Flow4. Radiopacity5. Solubility	1. 23 minutes2. 130 minutes3. Minimum of 20 mm4. Minimum of 3 mm5. Maximum 3%
	Internal Tests
	1. Flow/Viscosity	1. Base Paste 20-22mm / Catalyst Paste27-29 mmMixed pastes after30 min 21-23 mm
	2. Radiopacity	2. Greater than 3mmof the aluminiumscale
	3. Setting time	3. 130 minutes
	4. Free lime content	4. 3-5%

The test methods are the same as those submitted in the original submission.

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Conclusion

MTA Fillapex has the equivalent indications for use, comparable chemical compositions, physical properties and performance specifications to K113568. The additional chemical component found in MTA Fillapex were found to be as safe and effective as the predicate.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, M1) 20993-0002

April 25, 2014

Angelus Industria de Productos Odontologicos C/O Tara Conrad TechLink International Consulting 18851 NE 29th Avenue Suite 720 Aventura, FL 33180

Re: K140247

Trade/Device Name: MTA Fillapex Regulation Number: 21 CFR 872.3820 Regulation Name: Resin, Root Canal Filling Regulatory Class: II Product Code: KIF Dated: March 14, 2014 Received: April 4, 2014

Dear Ms. Conrad:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Conrad

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Susan Rinno, DDS, MA

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Device Name: MTA Fillapex

510(k) Number: K140247

Indications for Use:

MTA-Fillapex is a root canal sealer intended for the permanent scaling of root canals and may be used in combination with root canal obturation materials.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ (21 CFR 801 Subpart C) .

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AND/OR

oncurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

Sheena A. Green -S 2014.04.25 12:35:13 -04'00'

Page 12 of 131 Special 510(k) MTA Fillapex

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.